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SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

NCT07422675 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-05

No results posted yet for this study

Summary

This is a randomized, placebo-controlled, single ascending dose (SAD) study of SER-252 in participants with Parkinson's Disease (PD) and motor fluctuations.

Conditions

  • PARKINSON DISEASE (Disorder)
  • Advanced Parkinson's Disease

Interventions

DRUG

SER-252 (PEOZ-apomorphine)

SER-252 drug product consists of 20mg lyophilized apomorphine equivalent in SER-252 drug substance in a sterile vial for reconstitution with a diluent product containing 15mM acetate buffer at pH 6.0 and 7% trehalose to maintain final pH and isotonicity in the reconstituted product.

DEVICE

enFuse

The enFuse® device is a sterile, non-pyrogenic, user-filled, single-use, fixed-dose subcutaneous dose delivery system.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07422675 on ClinicalTrials.gov